UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034068 |
|---|---|
| Receipt number | R000038832 |
| Scientific Title | The efficacy of interval walking training in rehabilitation medicine for mild heart failure patients |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/09/08 08:38:12 |
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Basic information
Public title
The efficacy of interval walking training in rehabilitation medicine for mild heart failure patients
Acronym
Application of interval walking training to rehabilitation medicine for mild heart failure patients
Scientific Title
The efficacy of interval walking training in rehabilitation medicine for mild heart failure patients
Scientific Title:Acronym
Application of interval walking training to rehabilitation medicine for mild heart failure patients
Region
| Japan |
Condition
Condition
Mild heart failure
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of interval walking training in rehabilitation medicine for mild heart failure patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak aerobic capacity
Key secondary outcomes
Peak heart rate
Ventiation threshold
Oxygen puslse (O2 pulse)
Left ventricular diastolic capacity (E/e')
Left ventricular ejection fraction(LVEF)
B type Na uretic peptide(BNP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cycling exercise training (30min/day, a day/ week)at the intensity above the anaerobic threshold
Interventions/Control_2
Cycling exercise training (30min/day, a day/ week) + Interval walking training (30min/day, 3days/ week) above the anaerobic threshold
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who had not increased peak aerobic capacity although they had undergone cycling exerice training 30min/day, a day/ week, for more than 6 months in a hospital.
2) Patients who are classified into level I or II according to the NYHA classification.
3) Patients in whom the left ventricular ejection fraction is less than 60%.
4) Patients in whom plasma Na uretic peptide concentration is more than 18.5 pg/ml.
5) Patients who give an informed consent to voluantarily particopate in the study.
Key exclusion criteria
1) Patients who are classified into the level II or III according to the NYHA classification.
2) Patients whose left ventricular ejection fraction is more than 60% and plasma Na uretic peptide is lower than 18.5pg/ml.
3)Patients whom a primary investigator and/or a cardiologist judge as irrerevant to participate in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shizue Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2681
Homepage URL
nosehir@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Cuture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
North Alps Medical Center Azumi Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 08 | Day |
Last modified on
| 2018 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038832
